BridgeMD
Compares treatment options for Generalized Myasthenia Gravis
Official title A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT06744920
What this study is testing
What is Remibrutinib (Blinded)?
Remibrutinib (Blinded) is an investigational medicine, being studied as a potential treatment for generalized myasthenia gravis.
Also referred to as LOU64.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult patients with gMG (age 18-75 years)
- Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the...
- Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK...
- Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms
- Participants who have been on a stable dose of standard-of-care treatment as specified in the protocol
You likely can't join if
- Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6...
- Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods...
See the full eligibility criteria
- Adult patients with gMG (age 18-75 years)
- Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator
- Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening
- Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms
- Participants who have been on a stable dose of standard-of-care treatment as specified in the protocol
- Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline
- Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other...
- Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Homestead, Florida, United States
- Maitland, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- East Lansing, Michigan, United States
- Buffalo, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
+ 95 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Fullerton, California, United States; Los Angeles, California, United States; Orange, California, United States; Sacramento, California, United States and 109 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.